Abstract 4305
Background
The EVIDENS study aims to describe clinical characteristics and health-related quality of life (HRQoL) of lung cancer patients treated with nivolumab in real-life in France and to assess its effectiveness and safety.
Methods
EVIDENS is an observational, multicenter, longitudinal cohort study of adult lung cancer patients treated with nivolumab. Survival was assessed using the Kaplan-Meier method and health-related quality of life (HRQoL) was assessed using EQ-5D-3L questionnaire.
Results
A total of 1,462 lung cancer patients were enrolled in the study from Oct 2016 to Nov 2017 in 146 French centers. Previous reports with a 8-month minimum follow-up showed that baseline patient and tumor characteristics from EVIDENS were representative of a standard advanced NSCLC population and that nivolumab was mostly administered as a 2nd line regimen. Median PFS and median OS was 2.8 months (95% CI: 2.6-3.0) and 10 months (95% CI: 9.2-11.0), respectively. Adverse events occurred in 440 patients (31.6%), including 98 patients (7.0%) with grade 3-4 events. Concerning HRQoL, mean change of visual analog score from baseline was statistically significant at 9 and 12 months and minimal important difference was achieved at 12 months for the squamous population. The analysis presented during the congress will include updated effectiveness, safety and HRQoL data as well as subgroups of interest (e.g. brain metastasis, age, prior radiotherapy) with a 17-month minimum follow-up.
Conclusions
TTo date, EVIDENS is the largest prospective observational study of nivolumab in lung cancer patients confirming effectiveness and safety in the real world setting. This updated analysis provides new insights on the experience of nivolumab over a period of longer follow-up and, for the first time, in clinically important subgroups of interest.
Clinical trial identification
NCT03382496.
Editorial acknowledgement
Legal entity responsible for the study
Bristol-Myers Squibb France.
Funding
Bristol-Myers Squibb France.
Disclosure
A. Dixmier: Advisory / Consultancy, Speaker Bureau / Expert testimony: Bristol-Myers Squibb; Advisory / Consultancy, Speaker Bureau / Expert testimony: Roche; Advisory / Consultancy: Novartis; Speaker Bureau / Expert testimony: AstraZeneca; Speaker Bureau / Expert testimony: Boehringer Ingelheim; Speaker Bureau / Expert testimony: MSD; Speaker Bureau / Expert testimony: Amgen; Speaker Bureau / Expert testimony: Lilly. D. Debieuvre: Honoraria (self), Advisory / Consultancy, Speaker Bureau / Expert testimony, Research grant / Funding (institution): Roche; Honoraria (self), Research grant / Funding (institution): AstraZeneca; Honoraria (self), Research grant / Funding (institution): Chugaï; Honoraria (self), Research grant / Funding (institution): Lilly; Honoraria (self), Speaker Bureau / Expert testimony, Research grant / Funding (institution): Novartis; Honoraria (self), Advisory / Consultancy, Speaker Bureau / Expert testimony, Research grant / Funding (institution): Pfizer; Honoraria (self), Advisory / Consultancy, Speaker Bureau / Expert testimony, Research grant / Funding (institution), Travel / Accommodation / Expenses: MSD; Honoraria (self), Advisory / Consultancy, Speaker Bureau / Expert testimony, Research grant / Funding (institution), Travel / Accommodation / Expenses: Bristol-Myers Squibb; Research grant / Funding (institution): Janssen; Research grant / Funding (institution): GSK; Travel / Accommodation / Expenses: Pierre Fabre; Travel / Accommodation / Expenses: Mundipharma. J.B. Auliac: Advisory / Consultancy, Non-remunerated activity/ies: Bristol-Myers Squibb; Advisory / Consultancy: Roche. N. Benoit: Advisory / Consultancy: Bristol-Myers Squibb; Advisory / Consultancy: AstraZeneca. D. Moro-Sibilot: Advisory / Consultancy: Roche; Advisory / Consultancy: Pfizer; Advisory / Consultancy: AstraZeneca; Advisory / Consultancy: Bristol-Myers Squibb; Advisory / Consultancy: MSD; Advisory / Consultancy: Lilly; Advisory / Consultancy, Research grant / Funding (institution): Boehringer Ingelheim; Advisory / Consultancy, Research grant / Funding (institution): AbbVie; Advisory / Consultancy: Takeda. C. Audigier-Valette: Advisory / Consultancy, Speaker Bureau / Expert testimony: AstraZeneca; Advisory / Consultancy, Speaker Bureau / Expert testimony: Boehringer Ingelheim; Advisory / Consultancy, Speaker Bureau / Expert testimony: Bristol-Myers Squibb; Advisory / Consultancy, Speaker Bureau / Expert testimony: Lilly; Advisory / Consultancy, Speaker Bureau / Expert testimony: Novartis; Advisory / Consultancy: MSD; Advisory / Consultancy, Speaker Bureau / Expert testimony: Pfizer; Honoraria (institution), Advisory / Consultancy: Roche. B. Asselain: Advisory / Consultancy: Bristol-Myers Squibb. P. Lamoureux: Full / Part-time employment: Bristol-Myers Squibb. F. Cotté: Full / Part-time employment: Bristol-Myers Squibb. V. Allan: Full / Part-time employment: Bristol-Myers Squibb. M. Daumont: Full / Part-time employment: Bristol-Myers Squibb. N. Ozan: Full / Part-time employment: Bristol-Myers Squibb. C. Calvet: Full / Part-time employment: Bristol-Myers Squibb. M. Perol: Honoraria (self), Advisory / Consultancy: Roche; Advisory / Consultancy: Lilly; Advisory / Consultancy: Bristol-Myers Squibb; Advisory / Consultancy: Pfizer; Advisory / Consultancy: MSD; Advisory / Consultancy: Boehringer; Advisory / Consultancy: Novartis; Advisory / Consultancy: Pierre Fabre; Advisory / Consultancy, Research grant / Funding (institution): AstraZeneca; Research grant / Funding (institution): Takeda; Advisory / Consultancy: Clovis. All other authors have declared no conflicts of interest.
Resources from the same session
4811 - Comprehensive genomic profiling of thymic carcinoma in a sample Chinese population
Presenter: Baohui Han
Session: Poster Display session 1
Resources:
Abstract
2045 - The analysis of treatment sequences and clinical outcomes of thymic carcinoma
Presenter: Arakaki Motoko
Session: Poster Display session 1
Resources:
Abstract
4785 - Transcriptomic Difference of Thymoma and Thymic Carcinoma
Presenter: Naixin Liang
Session: Poster Display session 1
Resources:
Abstract
2864 - A Phase II Trial of Preoperative Chemoradiotherapy and Pembrolizumab for Locally Advanced Esophageal Squamous Cell Carcinoma (ESCC)
Presenter: Seoyoung Lee
Session: Poster Display session 1
Resources:
Abstract
5015 - The study of tumor associated exosomes in crosstalk between esophageal carcinoma and lymphatic endothelial cells
Presenter: Weimin Mao
Session: Poster Display session 1
Resources:
Abstract
1339 - Up-regulation of IBSP expression predicts poor prognosis of Esophageal Squamous Cell Carcinoma patients
Presenter: Mingyue Wang
Session: Poster Display session 1
Resources:
Abstract
4083 - PD-L1 expression in primary tumour vs metastatic samples in the Phase 3 MYSTIC study in first-line metastatic (m) NSCLC
Presenter: Niels Reinmuth
Session: Poster Display session 1
Resources:
Abstract
5113 - Assessing the impact of subsequent checkpoint inhibitor (CPI) treatment on overall survival: post hoc analyses from the phase 3 JAVELIN Lung 200 study of avelumab vs docetaxel in platinum-treated locally advanced/metastatic non-small cell lung cancer (NSCLC)
Presenter: Fabrice Barlesi
Session: Poster Display session 1
Resources:
Abstract
4256 - Long-term avelumab treatment in patients with advanced non-small cell lung cancer (NSCLC): post hoc analyses from JAVELIN Solid Tumor
Presenter: Borys Hrinczenko
Session: Poster Display session 1
Resources:
Abstract
5128 - IO-Synthesise NSCLC: A pooled analysis of real-world survival outcomes for non-small cell lung cancer patients treated with nivolumab in France and Germany
Presenter: Adrien Dixmier
Session: Poster Display session 1
Resources:
Abstract